9/3/2013 10:01:35 AM
Dublin, Ireland, 3rd September, 2013 – ICON plc, (NASDAQ: ICLR) a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the third in its four-part Solution Provider educational webinar series in collaboration with DIA.
On September 12th 2013, ICON and DIA will present Measurement in Clinical Trials: An Examination of the FDA Position on the Review of Clinical Outcome Assessments (COAs). Bringing together leading scientists and thought leaders from the biopharma industry, the webinar will cover:
- Classifications and definitions of COAs
- FDA evidence requirements for Patient Reported Outcomes (PROs)
- Challenges and experiences of evaluating non-PRO COAs to PRO standards
- Industry perspective on the FDA position on review of COAs
Ms Emuella Flood, Director Patient-Reported Outcomes at ICON, said: “We are very excited to be a part of this joint effort with DIA to discuss the important and timely topic of COAs for use in drug development. In this webinar, we will focus particularly on clinician-reported outcomes, which is an area of much discussion among COA researchers. We plan to highlight some of the challenges of applying the PRO guidance to these types of instruments and will consider possible solutions for addressing these challenges.”
Susan Cantrell, Director, North America at DIA said, “It is DIA’s mission to transfer knowledge and timely and pertinent information to health care professionals across the globe. This series of educational webinars, and this webinar in particular, addresses specific needs for professionals in the areas of medical product development, outcomes research and regulatory affairs. Through our panelists’ expertise, webinar attendees will be given vital insights and information which will undoubtedly enhance their professional growth.”
The webinar will feature the following experts:
- Emuella Flood, Director Patient-Reported Outcomes – ICON Late Phase and Outcomes Research
- Cicely Kerr, PhD,MSc, Senior Outcomes Researcher, Patient Reported Outcomes
ICON Late Phase and Outcomes Research
- April N Naegeli, DrPH,MPH, Research Scientist, Global Health Outcomes – Eli Lilly and Company
The ICON-DIA Webinar Program brings ICON experts together with leading scientists and thought leaders from the biopharma industry to present four 90-minute webinars throughout 2013. Previous webinars were Biomarker Strategies for More Efficient Early Phase Drug Development in Alzheimer’s Disease; and Oncology Clinical Trial Endpoints – Keys to Maximizing Success in your Development Programs.
The statements made in this press release may contain forward-looking statements that involve a number of risks and uncertainties. A description of risks and uncertainties relating to ICON and its business can be found in Forms 20-F for the fiscal year ended December 31st 2012 and in the other forms filed with the US Securities and Exchange Commission, including the F-1, S-8 and F-3. ICON disclaims any intent or obligation to update these forward-looking statements.
About ICON plc
ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. ICON currently has approximately 10,170 employees, operating from 78 locations in 37 countries.
Further information is available at www.iconplc.com
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and wellbeing worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China.
Further information is available at www.diahome.org
ICON Media Contact
Tel: +44 (0)20 7067 0655
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